– Hosted by Key2Compliance
There are a large number of new start-ups in Medical Device and In Vitro Diagnostics in the Medicon Valley area. This seminar will focus on how a start-up in Medical Device or In Vitro Diagnostic can accelerate the development from idea to success within the current framework of regulations.
Join us for an afternoon of presentations, discussions, experience sharing and a chance to network and mingle. All in the interest of making the start-ups in the Medicon Valley area as competitive as possible.
Who should attend?
This seminar is intended for anyone working in a start-up or smaller Medical Device or In Vitro Diagnostic Company that at present or in the future will manage a product development from concept to success.
Date: 2nd of June 2022
Time: 13.00-17.30
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Meeting room: Auditorium
Program
| 13.00 | Registration & Coffee |
| 13.15 | Welcome and introduction to Medicon Valley Alliance and Key2Compliance David Munis Zepernick, Head of Member Engagement and Communication Jan Hellqvist, CEO, Key2Compliance |
| 13.20 | The need of early engagement and regulatory considerations in the initial phase of medical device development Tomas Camnell, Strategic Director Medical Device, Key2Compliance |
| 13.45 | Start with the end in mind Ina Laura Perkins, CEO, Scandinavian Real Heart |
| 14.10 | How to work with a Notified Body Charlotte Hess, Business Development Manager (IVD) EMEA North, BSI |
| 14.35 | Coffee and networking |
| 15.00 | Our startup journey from idea to market Christoffer Ekström, CEO, AI Medical Technology |
| 15.25 | Apply a clinical strategy early to optimize your device development Maria Lindgren, Director Clinical Development, Key2Compliance |
| 16.00 | Material Choices & Biocompatibility – making the right decisions early for efficient product development Emma Pedersen, Director Biological Evaluation & Toxicology, Key2Compliance |
| 16.25 | Close and outstanding questions |
| 16.30 – 17.30 | Mingle, networking, drinks, and light refreshments |
Speakers
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| Jan Hellqvist (Moderator) CEO Key2Compliance |
Tomas Camnell Strategic Director Medical Device Key2Compliance |
Ina Laura Perkins CEO Scandinavian Real Heart |
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| Charlotte Hess Business Development Manager (IVD) EMEA North BSI |
Christoffer Ekström CEO AI Medical Technology |
Maria Lindgren Director of Clinical Development Key2Compliance |
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| Emma Pedersen Director Biological Evaluation & Toxicology Key2Compliance |
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